R&D Engineer: Innovate, Validate & Launch New Products

Katalyst CRO; San Jose (CA); On-site; USD 120,000 - 150,000; Full time

Job summary

Katalyst CRO in San Jose, CA is seeking an innovative R&D Engineer to support the research, design, development, and validation of new products and technologies. You will collaborate with cross-functional teams to transform concepts into commercially viable products while ensuring compliance with quality, regulatory, and customer requirements.

This role covers design, prototyping, testing, risk analysis, and continuous product improvement.

Qualifications

• Bachelor's degree in Mechanical, Biomedical, Electrical, Manufacturing, or related engineering.
• 38+ years of experience in Research & Development, Product Development, or Design Engineering.
• Experience with product design, prototype development, testing, and engineering documentation.
• Proficiency in CAD software such as SolidWorks, Creo, CATIA, AutoCAD, or Siemens NX.
• Strong understanding of engineering principles, materials, and manufacturing processes.
• Experience with Design Verification & Validation (V&V).
• Knowledge of Design Controls, Risk Management, and Design Reviews.
• Strong analytical, problem-solving, and troubleshooting skills.
• Excellent written and verbal communication skills.
• Ability to work effectively in a cross-functional team environment.

Responsibilities

• Design, develop, and improve new products, components, and manufacturing processes.
• Support all phases of product development, from concept through commercialization.
• Create engineering drawings, specifications, and technical documentation.
• Develop prototypes and conduct feasibility studies to evaluate product performance.
• Plan and execute design verification and validation (V&V) testing.
• Perform root cause analysis and implement corrective actions for product and process issues.
• Conduct Design Failure Mode and Effects Analysis (DFMEA), Process FMEA (PFMEA), and risk assessments.
• Collaborate with Manufacturing, Quality, Regulatory, Supply Chain, and Operations teams to support design transfer and production readiness.
• Support process validation activities, including IQ/OQ/PQ, as required.
• Analyze test data and prepare engineering reports and technical presentations.
• Ensure compliance with applicable industry standards, regulatory requirements, and company quality systems.
• Drive continuous improvement initiatives to enhance product quality, reliability, and manufacturability.
• Participate in design reviews, technical risk assessments, and engineering change activities.

Education

Bachelor's degree in Mechanical Engineering or related field

Tools

SolidWorks

Creo

CATIA

AutoCAD

Siemens NX

Job description

Katalyst CRO in San Jose, CA is seeking an innovative R&D Engineer to support the research, design, development, and validation of new products and technologies. You will collaborate with cross-functional teams to transform concepts into commercially viable products while ensuring compliance with quality, regulatory, and customer requirements.

This role covers design, prototyping, testing, risk analysis, and continuous product improvement.